The present disclosure relates generally to packaged medical device assemblies and more specifically to combinations of packages with medical devices.
Certain drugs are supplied in lyophilized form. The lyophilized drug must be mixed with water to reconstitute the drug into a form suitable for injection into a patient. In particular, the components that form the injectable solution must be sterile to avoid infection. The reconstitution process presents difficulties to patients or caregivers who need to inject themselves or another, for example, in a home environment. The patient or caregiver has to follow a sequential manipulation of the drug container, the diluent container and the transfer syringes, which use needles to penetrate the stoppers associated with the respective containers. The patient or caregiver needs to follow established aseptic practices to avoid contamination.
As described in the '967 Application, the drug container, the diluent container and the transfer syringes of the device are mounted within a same housing at time of shipping from the manufacturer, distributor or assembler to the end user. Due to the specific arrangement of the transfer syringes with respect to each of the drug containers, extra care is taken to prevent accidental premature puncture or activation of the stoppers of the containers by the transfer syringes during shipment and handling. Shipment of reconstitution devices accordingly presents challenges in preventing premature activation of the product, ensuring sterility and enabling ease of use of the product by the end user. The lyophilized drugs are often very expensive, making the minimization of accidental activation or contamination suffered during shipment even more important.